Pharmacokinetic and Safety Study of MRX-2843 in Adolescents and Adults With Relapsed/Refractory AML, ALL, or MPAL

Active:	Yes
Cancer Type:	Leukemia	NCT ID:	NCT04872478
Trial Phases:	Phase I	Protocol IDs:	2843-1003 (primary) NCI-2021-13604
Eligibility:	12 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Meryx, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT04872478

Summary

This is a Phase I, open-label, non-randomized, dose escalation study in adolescents and
adults with relapsed/refractory acute myeloid leukemia, acute lymphoblastic leukemia, or
mixed phenotype acute leukemia. Patients will receive continuous oral MRX-2843 in 28 day
cycles at predefined dose cohorts.

Objectives

This is a Phase I, open-label, non-randomized, dose escalation study in up to 50
adolescent or adult patients with relapsed/refractory acute myeloid leukemia, acute
lymphoblastic leukemia, or mixed phenotype acute leukemia. Patients will receive a single
dose of MRX-2843 followed by continuous oral MRX-2843 in 28 day cycles at predefined dose
cohorts.

A dose expansion arm of approximately 12 patients (with 6 patients being FLT3 ITD+ and 6
patients being Mer+/FLT3 WT) will be accrued to further evaluate patients at the RP2D.

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